跳至主要内容
临床试验/NCT02102321
NCT02102321Unknown不适用

A Randomized Effectiveness Trial of Hookworm Treatment of Women Smallholder Farmers to Evaluate Improved Productivity of Their Farming and/or Household Labor

Salmon, Margaret, M.D.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Exercise Tolerance Harvard STEP Test

研究概览

简要总结

Treatment of hookworm infected groups with albendazole has been shown to result in an increase in hemoglobin levels and a related decrease in the prevalence of anemia. Increases in hemoglobin levels due to treatment have been associated with significant gains in adult labor productivity.

In this study, the investigators hypothesize that regular treatment of women smallholder farmers in a high prevalence area with the anti-hookworm drug albendazole and iron supplementation will improve hookworm associated anemia. Further, regular treatment of albendazole and iron supplementation will improve their work capacity when compared to a control group

详细描述

DRC has one of the world's highest prevalences (frequencies) of Soil Transmitted Helminths (STH), a group of intestinal parasites that include Ascaris, Trichuris and hookworm, each of which can have significant impacts on the health and nutritional status of children.(1)(2)(3) In addition, hookworm, because of prevalence increases noted during adulthood in many countries and because of its relationship to significant intestinal blood loss, can also have a significant impact on the health and nutritional status of adults.

Hookworm spreads easily in places without adequate control of feces; hookworm eggs are excreted in feces of infected people, transition to larvae, and usually enter the body through the skin on the bottom of the feet of other people who are not wearing footwear.

Much of hookworm's health impact is mediated through intestinal blood loss as hookworms attach to the human intestinal wall and digest the hemoglobin in human red blood cells. That blood loss leads to - or exacerbates - iron deficiency and eventually to iron deficiency anemia (IDA). Because of menstrual blood losses, the large iron demands of pregnancy, and the often low iron content of their diets, many women of childbearing age are at risk of iron deficiency even without hookworm exposure. Any blood loss associated with hookworm infection would exacerbate a pre-existing iron deficiency.

Iron deficiency with or without anemia has also been associated in several studies with lower aerobic work capacity. IDA can effect an individual's ability to perform economic generating tasks (work output) threaten one's livelihood and possibly food security. The World Health Organization (WHO) estimates an annual loss of 19.7 million disability-adjusted life years (1.3% of the global total) is due to IDA with high burden in Africa (25%), an area which can least afford it. The median annual economic loss due to IDA has been estimated at 4% of gross domestic product in 10 different developing countries.

Albendazole and Mebendazole are anti-helminthic drugs that that can cure or reduce the severity (as measured by stool egg counts) of many hookworm infections. The major programmatic use of these drugs is in programs of school-based mass drug administration (MDA) as recommended treatment strategies have traditionally prioritized school-aged children. Large amounts of these drugs are now being provided without charge by their manufacturers, Merck and Johnson & Johnson respectively, and distributed through W.H.O. and ministries of health to support current goals of control of pediatric hookworm and other STH infections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
17 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All women of childbearing years (age 16 - 50)
  • Identify as a small subsistence farmer
  • No clinical evidence of acute malaria, who are with hookworm + stool, and are not pregnant.
  • If women become pregnant during the period of study and tests + at the 6 or 12 month study visit then based on last menstrual period, we will wait until she has completed her first trimester to initiate the 6 or 12 month study visit based on protocol.

排除标准

  • Women with acute symptoms of malaria
  • 1st trimester pregnancy
  • Hookworm - stool
  • Declines study participation
  • Age <16 or > 50
  • Muscular or neurologic defect that preclude them from stepping on and off a stairs
  • Cognitive impairment such that they cannot understand study purpose and consenting procedure

研究组 & 干预措施

placebo

Active Comparator

placebo

干预措施: placebo (Drug)

albendazole

Experimental

albendazole 400 mg

干预措施: albendazole (Drug)

结局指标

主要结局

Exercise Tolerance Harvard STEP Test

时间窗: 12 months

Subjects exercise tolerance will be measured as amount of time able to step on and off the Harvard Step and the heart rate as measured in beats per minute after a 5 minute step interval

次要结局

  • hemoglobin(12 months)
  • albendazole efficacy(12 months)

研究者

发起方
Salmon, Margaret, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Does Treating Hookworm Improve Productivity of Small... | 临床试验